Which Approach to ISO 9001 Certification Is Best for You?
The Ideal Route Depends on Your Situation

Table of Contents

The realization that you're "The One" responsible for managing an organization's ISO 9001 certification can elicit mixed emotions. When an organization starts a new project that has wide-ranging effects across the entire business, it's likely they'll need some assistance, education, and development unless they already have all the internal knowledge and resources required. Implementation of an ISO 9001 compliant quality management system (QMS) touches everyone in the organization, but it's the people tasked with driving the process that are impacted first.

Have You Been Tasked With ISO 9001 Certification for Your Organization?

If you're a business owner or a member of the executive management team, you'll understand only too well the importance of gaining the ISO 9001 certificate. Not only does it open doors to new contracts and provide excellent marketing opportunities but you've heard it can make your business more efficient as well. But if you have little or no idea of what the certification process entails, where do you start?

Tasked with ISO 9001 Implementation

Or perhaps you're the 'lucky' employee, plucked from the ranks to 'sort this ISO thing out.' You're known as a person who gets things done which is why you've been chosen. It's an opportunity to step up and shine, but with little or no knowledge of ISO 9001 and quality management systems, and possibly no real authority to make the rest of the organization comply with your directives, the prospect is both exhilarating and terrifying. What's the first thing you should do?

If you're a middle manager or department head with an already full schedule and you're asked to get your work areas in shape for ISO 9001 certification with no additional resources and only a vague idea of what's needed, your stress and frustration levels are likely to rise. Your focus will be on the easiest way to get things done, in the least amount of time, with minimal impact on operations and cost. How are you going to pull that off?

If the organization has bitten the bullet and hired you as their new Quality Manager, they've placed their money and faith in you to manage this mission-critical project. The pressure is on you to perform and get systems and processes up and running quickly. You may have experience in both the certification process and the requirements of ISO 9001:2015, and have learned from mistakes on previous projects, but you still need to set up the system from scratch and work out how to apply each element of the standard to the way your new organization works.

Ideally, anyone responsible for driving the project is aware of the common mistakes to avoid and feels excited at the potential for improved business processes as well as access to new contracts and marketing opportunities. They'll understand that the long-term success of the QMS depends on everyone in the organization being involved and taking ownership, and that implementing new systems and procedures doesn't mean creating a bureaucracy.

A 2018 study by by the 9001 Council into international surveys on the effectiveness of hiring external consultants shows that organizations that remain the most enthusiastic and positive about the implementation of ISO 9001 are those who've done so to obtain internal efficiencies rather than because of external pressures. As they note, "the result is more likely to be a workable system that leads to greater quality awareness, better awareness of problems within the organization and improved product quality."[1]

No matter what role the key facilitators have in the organization, their reality is usually one or more of the following:

A finite, and often restrictive budget

Tight time frames

A need to educate the entire organization about the ISO 9001 standard and how to apply its requirements to individual work areas.

If those tasked with the certification aren't 100% confident in their knowledge and abilities to successfully implement the requirements of the standard, the temptation to hire in external expertise to get the project finished as soon as possible is real. However, it's a rare organization that has an unlimited budget. Small and medium enterprises (SMEs) especially need to weigh up the time and effort required of internal employees with the substantial costs of hiring an external consultant.

It seems this quandary has been around since the very early days of ISO 9001 certification. A 1997 study by Brown et al., which looked at the experience of smaller enterprises with ISO 9001, revealed:

"The costs of bringing in a consultant are quite often mentioned as prohibitive; however, the pressure to get ISO 9000 series certification combined with the lack of knowledge, and the lack of time, are forcing small businesses to look for external support."[2]

In the following article, we explore the pros and cons of using and developing an organization's internal capacity and capability vs. engaging an external consultant or utilizing external resources for quality systems implementation.

Different Approaches to ISO 9001 Certification

We examine four different approaches that an organization can take to develop an ISO 9001 compliant Quality Management System (QMS). Note that there are numerous variations on these four options, however, pros and cons of the different characteristics still apply.

Approach 1: Use Internal Facilitators to Develop Your ISO 9001 Compliant QMS

Businesses who take this approach design and develop their QMS internally without outside help. They also create and deliver training using internal resources. This approach works well when the primary facilitators of the project have:

Knowledge in the requirements of the ISO 9001 standard

A good understanding of how the business works and who the key internal influencers are (official and unofficial)

The ability to interpret and apply the requirements of the standard to the organization

Skills in designing systems, processes, and supporting documentation

Visible support from Top Management who acknowledge their expertise and role in the project and communicate that throughout the organization

Resources to create and deploy training across the whole organization (e.g., ISO 9001 basics, QMS procedures, Internal Audit skills etc.)

A QMS developed using this approach is likely to complement the way the organization does business, create efficiencies, and promote a high degree of ownership that contributes to long-term sustainability and continuous improvement. Any knowledge, skills and expertise developed during the project are retained within the organization.

Drawbacks to Approach 1

Without at least a basic understanding of the requirements of the ISO 9001 standard, the initial phase of the project can stall as the organization comes to grips with what's required, then develops systems and procedures from scratch, using trial and error until they find out what works for their unique situation. If employees feel that those facilitating the project aren't fully competent they may lose confidence in the success of the initiative and withdraw their support and involvement.

Employee frustration and stress can increase if resources are limited and the certification tasks come on top of their existing responsibilities.

Critics of this approach point out that a slow start-up phase can dampen initial enthusiasm, increase the time to obtain the certification, and cause conflict.[3]

Developing and deploying training in ISO 9001 requirements, the certification process, and the new QMS procedures across the entire organization also requires significant time and effort. So while using internal resources might seem the least expensive option at face value, this approach might work out quite costly in the long term.

Pros and Cons of Using Internal Facilitators for ISO 9001 Certification


Internal facilitators:

Already understand company processes, culture, and key influencers

Can interpret the requirements of the standard for business improvement

Mean knowledge, skills, and resources developed during the process remain in-house

Create acceptance and ownership of the QMS across the organization

Create a QMS that is more sustainable long term


Internal facilitators:

May have a lack of internal expertise in ISO 9001 & certification resulting in a slow start-up phase

Require significant effort to set up documents, forms, procedures, and systems from scratch

May not inspire confidence because of their lack of expertise which can dampen support

May require external training that can be costly

May turn out more expensive once their time is included in implementation costs

Approach 2: Engage a "Hands-On" External Consultant

When we talk about a "hands-on" consultant, we're referring to someone who plays a direct role in directing and developing the different aspects of the QMS. They bring a fresh set of eyes to the organization's certification process and expertise in ISO 9001. They write the quality policies and documentation and set up different aspects of the system such as the internal audit program, corrective action and risk-based thinking procedures, and management review. They are more like a contractor or a spare set of hands than an adviser and perform tasks the business doesn't have the time, knowledge or skills to do themselves. The consultant may be engaged for the whole project or specific phases. In organizations where there are few resources available in the native language, the consultant can play an important role in translating the requirements.

This approach works well when the organization:

Clearly defines the objectives of the project and the benefits they want the QMS to deliver

Sets up clear deadlines and performance indicators for each stage of the project

Requires the consultant to consult internal team members and understand how the business operates before developing the QMS

Oversees and authorizes all aspects of the QMS after consultation with those affected

Nominates a quality representative to manage communication and arrangements with the certification body and external auditors

Implements a comprehensive handover process at the end of the project to ensure long-term sustainability and transfer of knowledge and expertise

Drawbacks to Approach 2

It's unlikely that an external consultant will have the necessary understanding of the organization initially to create a QMS that fits the business. Gaining this understanding is time-consuming, and costs can escalate quickly as the billable hours add up.

If the hands-on consultant is tasked with certification as the primary aim rather than long-term sustainability and business improvement, they may develop the system, write the manuals, and micromanage the processes in isolation resulting in a bureaucratic system that hinders the way the business operates and is impossible to maintain.

Eventually, the consultant will need to hand over the QMS to the business, and the Quality Representative will need to be up to speed to manage, maintain, and improve it successfully. But how can they expect to be fully capable if they weren't intimately involved in setting the systems up in the first place?

Full-time employees who don't have any direct involvement in building the quality system may not have an incentive to own their responsibilities within the system, and it can collapse when the consultant leaves.

If the consultant takes over and plays the primary role in facilitating the organization's external audit, the certification body may interpret that as a sign the business is not ready for ISO 9001 certification.

Without clear performance measures and firm deadlines, there is no incentive to finalize the project. The longer the consultant is required, the more they get paid overall.

A recent survey carried out by the 9001 Council found that hands-on consultants, "were generally viewed favorably during the implementation phase (principally because they were deemed helpful and did most of the work), but much less so after they had moved on. The reasons for this were twofold: first, the consultant's micromanagement of the project created a dependency which left managers and employees struggling once the consultant's contract expired; second, companies were generally less satisfied with their Quality Management Systems, in some cases describing them as "not what we were expecting", "inappropriate for our needs", and even "unworkable."[1]

Pros and Cons of a Engaging a Hands-On External Consultant


Hands-on consultants:

Have expertise in the requirements of the standard

Bring a fresh set of eyes to the project

Give the organization flexibility regarding the amount and time frames of their involvement

Lend some credibility to the project because of their expertise

Can translate the requirements of the standard into the native language

Can reduce the time and effort to obtain certification by providing hands-on support

Have high approval and client satisfaction during the implementation phase[1]


Hands-on consultants:

Require time to familiarize themselves with organization's operations

May create a lack of ownership of the QMS by the organization

Some payment models offer no incentive to finish the project quickly

Costs can mount up rapidly. Good consultants can charge $150/hour or more (over $1000/day)

Have lower approval and satisfaction after implementation as the resulting system is often unsustainable[1]

Approach 3: Engage a "Hands-Off" External Consultant

In contrast with the hands-on approach discussed above, a hands-off consultant acts more like a coach. They also bring knowledge of quality systems and certification to the organization, but rather than directing and "doing" they help management and employees understand the requirements of the ISO 9001 standard and encourage them to create systems, procedures, and processes themselves. The hands-off consultant's main aim is to work themselves out of their role as the organization learns and develops. They should:

Help lay out a strategy for the implementation of the QMS and organize the necessary resources

Encourage and motivate employees to perform the tasks necessary to achieve certification

Assist everyone to stay on track, work through the solutions to problems, and remove barriers to progress.

This approach can work well if:

The organization has the people and time available to develop the documents, systems, and processes under the consultant's guidance

The consultant has a history of success working with a range of different companies and can customize their methods to the organization's unique situation

The consultant understands from first-hand experience the costly mistakes organizations make when implementing ISO 9001 and helps the business avoid them

The organization sets up clear and achievable milestones and performance measures to ensure the project stays on track

The organization has enough budget to fund the consultancy until the quality management system is established and is sustainable long term using in-house personnel and resources

Drawbacks to Approach 3

External consultants will take time to familiarize themselves with the organization and the way it works. While they bring experience and unbiased insight into the requirements of ISO 9001 and the certification process, it will take time to pass that knowledge onto the business so they can then establish a sustainable QMS that adds value to the organization.

A hands-off approach may take longer than hands-on methodology as the consultant must wait for personnel to complete tasks before they can move onto the next step. If resources are stretched and torn between maintaining business as usual and the extra tasks required by the project, things can move slowly and resentment may build.

Most consultants bill on an hourly or daily rate so costs can escalate quickly. It's important to lay down some clear deliverables and performance criteria to avoid budget blowouts as the best consultants cost hundreds of dollars an hour.

Feedback gathered by the 9001 Council about hands-off consultants was the mirror image of that received about their hands-on counterparts, revealing they were "viewed less favorably during the implementation process, but were held in much higher esteem in the months following certification. Once staff and managers had been trained to get the most out of the Quality Management System and could see the benefits it brought, the company's perception of the consultant changed markedly."[1]

Pros and Cons of "Hands-Off" External Consultants


Hands-off consultants:

Have expertise in the requirements of the standard

Facilitate ownership of the system rather than create the QMS themselves (vs. hands-on)

Create a more sustainable QMSs than the hands-on approach

Can translate the requirements of the standard into the native language

Have higher approval and client satisfaction after the implementation phase than a hands-on approach[1]


Hands-off consultants:

Require time to familiarize themselves with organization's operations

Need significant time and effort by the organization's employees to achieve the certification

Could be seen as imposters who create extra work and implement unwelcome changes

Costs can mount up rapidly. Good consultants can charge $150/hour or more (over $1000/day)

Approach 4: Use Internal Facilitators, Supported by an ISO 9001 Implementation Package

This fourth approach uses internal personnel as the primary facilitators (Approach 1) but incorporates resources from a comprehensive ISO 9001 implementation kit, to support them during the project.

A good package includes document templates, detailed implementation and customization guides, forms and checklists, and online or multi-media training tools that complement the rest of the resources. Ideally, the resources should be developed by industry experts and include access to experienced customer service or, even better, free consulting.

This approach achieves many of the benefits of the other three discussed above, without some of the drawbacks and hefty price tag. It can work well because:

The primary facilitators are internal employees who already know the organization, and its culture and processes so there's no lag time getting up to speed

Internal facilitators also have a good understanding of how the business works and who the key internal influencers are (official and unofficial)

Using a comprehensive ISO 9001 certification kit reduces the time necessary to develop the QMS without having to hire an external consultant

The customizable templates, facilitation manuals, and training provide support similar to that expected from a hands-on consultant

Employees are more likely to take ownership of the system when they develop it themselves as opposed to someone doing the work for them

When the tools offered by a comprehensive ISO 9001 implementation kit are accompanied by expert customer support and guidance, the organization can gain benefits similar to those provided by a hands-off consultant. The resources in the kit help guide the organization through the certification process and provide coaching on how to adapt the requirements of the standard to the business. If the facilitators have any questions or need advice, they can tap into the expertise of the resource creators by phone or email

The skills that employees gain while developing the QMS will remain with the organization long term

Purchasing a certification package to support the efforts of internal facilitators is more expensive initially than using no external resources at all. However, the costs are significantly less than hiring an external consultant. Besides, the amount of time saved by providing a framework to work from is substantial, and will quickly reduce the overall cost of the initiative when compared with going it completely alone as described in Approach 1.

Drawbacks to Approach 4

If the organization simply takes the templates provided in the implementation kit and doesn't customize them, the documents won't reflect the company's operations, nor improve the way it does business. The resulting QMS will be inefficient and therefore not sustainable long term.

So while a good quality ISO 9001 implementation package will provide a cost-effective way to reduce the time and effort required to achieve certification, the organization must still assign enough resources to apply the tools to the business. The more detailed and straightforward the customization instructions in the kit are, the smoother this process will be and the more likely the resulting QMS will help the company improve.

If the instructions in the kit aren't comprehensive and don't address the particular circumstances of the company, it's possible for the certification project to get stuck. Then, if the customer support provided as part of the package doesn't help the business work through those roadblocks, they may feel they need to revert to the services of an external consultant, defeating the purpose of using the kit in the first place.

At 9001Simplified, we offer a highly flexible template kit with extensive customization instructions that can be deployed across a wide range of industries, organizations and operational circumstances. Our customers can automatically configure key characteristics of our products prior to purchase, significantly improving and simplifying ISO 9001 implementation. We're so confident in the quality of our products, we offer free and unlimited e-Consulting as a standard inclusion in our best selling ISO 9001 certification kit. If a customer has a specific situation that is not addressed in the instructions or has an unusual circumstance that requires an unconventional approach to ISO 9001 processes, the expert team from 9001Simplified will help them work through the issue to find a solution and ensure the plan proposed is valid.

Internal Facilitation Supported by a Comprehensive ISO 9001 Implementation Kit


Internal facilitators supported by an ISO 9001 kit:

Have existing knowledge of company processes and culture

Understand who influencers are and can leverage their cooperation

Have a good chance of interpreting the requirements of the standard and customizing to the organization

Get the implementation started quickly and reduce trial and error

Reduce the effort required from internal facilitators as they have a foundation to work from

Retain knowledge and skills developed during the project in-house

Deliver online and multi-media training products that provide greater flexibility for deployment across busy organizations

Are less expensive than engaging an external consultant


Internal facilitators supported by an ISO 9001 kit:

Require funds to purchase the ISO 9001 Implementation kit

Require resources to customize the implementation kit to the organization


From our observations, it's evident that depending on the internal knowledge, time frames for certification and budget, there are several approaches to ISO 9001 certification that can be successful.

If members of the organization have a good grasp of the requirements of the standard, internal facilitators can develop a custom QMS that enhances the way an organization functions and provides a foundation for long-term business improvement.

External consultants can be of great assistance to an organization that has minimal knowledge of the standard and processes, but the costs can be significant.

Hands-on consultants will likely see results faster, but organizations need to make sure that knowledge is transferred and the resulting system complements the way their business works.

Hands-off consultants seem to achieve better results long term when compared to hands-on consultants. However, the impact on internal resources can be significant, and it will take time to bring company employees up to speed.

If the organization lacks knowledge and expertise in ISO 9001 and certification, or when time frames are tight, supporting internal facilitators with a comprehensive ISO 9001 implementation kit, can be an ideal solution. The kit will expedite the start-up phase and help employees create a customized QMS that supports the way the business operates and is sustainable long term.

Comparing Four Implementation Approaches

Surveys show, internal ownership is one of the most significant long-term success factors for a QMS whatever approach is taken.[1]

It's important that the focus during implementation remains on enhancing your business operations for increased productivity; reducing rather than increasing bureaucracy; ensuring the system supports rather than hinders the way your organization works; making sure skills, ownership and responsibility for maintaining the system are retained internally; and creating a QMS that is sustainable long term and supports continuous improvement.


After decades assisting organizations with ISO 9001 certification, the experts at 9001Simplified believe that using internal facilitators supported by an external implementation kit is the best solution for many organizations. We've found that while most businesses require assistance on their certification journey, they don't necessarily have the big budget necessary to hire a good consultant. That's why we created a range of comprehensive, yet straightforward and business-oriented tools that don't cost the earth.

The 9001Simplified products incorporate our unique, "simplified" approach to ISO 9001, which is goal-oriented and geared towards adding real value to your business. Our system not only facilitates a cost-effective ISO 9001 certification, but it will also enhance your business operations and lead to increased productivity. See for yourself how the 9001Simplified System benefits you now, and in the future as an ISO 9001 certified company.

Read more about How to Get ISO 9001 Certified the 9001Simplified way or discover our flagship ISO 9001 Certification Package and get your organization's Quality Management System on track today.


    Which approach do you think is right for your organization? Let us know your choice and why in the comments below (all relevant, respectful feedback is welcomed per our guidelines).


    1 "Small businesses: should you use an ISO 9001 consultant?", 9000 Council

    2 Brown, Alan; Van der Wiele, Ton; Loughton, Kate (1997), "Smaller Enterprises' Experiences with ISO 9000", International Journal of Quality & Reliability Management, 15(3): 273-285, ISSN: 0265-671X

    3 Boudreaux, Miriam (2009), "Do You Need a Consultant to Achieve ISO 9001 Certification?" Quality Digest

    4 Russo, C.W. (2000) "How to Hire an ISO 9000 Consultant", Quality Digest

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